Warnings

Contraindications

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine

Cautions

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give the vaccine should be based on careful consideration of the potential benefits and risks; the 1976 swine influenza vaccine was associated with an elevated risk of GBS, although evidence for a causal relationship of GBS with other influenza vaccines is inconclusive

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine

The immune response in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals

Syncope may occur in association with administration of injectable vaccines

May not protect all vaccine recipients against influenza disease

Drug interaction overview

Data are not available to assess concomitant administration with other vaccines; if coadministered with other injectable vaccines, administer at different injection sites

Immunosuppressive or corticosteroid therapies may reduce the immune response to the vaccine

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Pregnancy & Lactation

Pregnancy

Not approved for persons aged <65 yr

Data are insufficient to establish risk with use during pregnancy

Animal studies

No vaccine-related fetal malformations or variations and no adverse effects on preweaning development were observed when trivalent vaccine form given to pregnant rabbits during organogenesis

Lactation

Not approved for persons aged <65 yr

Data are not available to assess effects on breastfed infants or milk production in breastfeeding women

Pregnancy Categories

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.

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Pharmacology

Mechanism of Action

Vaccine contains inactivated influenza viruses (2 subtypes for A and 2 subtypes for B) that are determined annually

Conveys active immunity via stimulation of production of endogenously produced antibodies

Manufactured using an egg-based process

It is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil

Squalene, a naturally occurring substance found in humans, animals, and plants, is highly purified for the vaccine-manufacturing process

Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual

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Administration

IM Administration

Gently shake each syringe (vaccine is a milky-white suspension)

Inspect visually for particulate matter and discoloration prior to administration whenever solution and container permit; if either condition exists, do not administer

Administer by IM injection, preferably in the region of the deltoid muscle of the upper arm

Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk

Storage

Refrigerate at 2-8ºC (36-46ºF)

Protect from light

Do not freeze; discard if the vaccine has been frozen

Do not use after expiration date

The syringe, syringe plunger stopper, and tip cap are not made with natural rubber latex

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Compare formulary status to other drugs in the same class.

Access your plan list on any device – mobile or desktop.

The above information is provided for general
informational and educational purposes only. Individual plans may vary
and formulary information changes. Contact the applicable plan
provider for the most current information.

View explanations for tiers and
restrictions

Tier

Description

1

This drug is available at the lowest co-pay. Most
commonly, these are generic drugs.

2

This drug is available at a middle level co-pay. Most
commonly, these are "preferred" (on formulary) brand drugs.

3

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs.

4

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

5

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

6

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

NC

NOT COVERED – Drugs that are not
covered by the plan.

Code

Definition

PA

Prior Authorization Drugs that
require prior authorization. This restriction requires that
specific clinical criteria be met prior to the approval of the
prescription.

QL

Quantity Limits Drugs that
have quantity limits associated with each prescription. This
restriction typically limits the quantity of the drug that will
be covered.

ST

Step Therapy Drugs that have
step therapy associated with each prescription. This restriction
typically requires that certain criteria be met prior to
approval for the prescription.

OR

Other Restrictions Drugs that
have restrictions other than prior authorization, quantity
limits, and step therapy associated with each prescription.